The FDA released a trio of guidances on Drug Supply Chain and Security Act (DSCSA) requirements for drugmakers to attach identifiers to their prescription drugs. Source: Drug GMP Report

The FDA warned four drug manufacturers over a variety of procedural shortcomings, including ones for process control and sterility. Source: Drug GMP Report

Westminster Pharmaceuticals recalled two of its thyroid drugs after manufacturing them with APIs sourced from a Chinese supplier the FDA cited for GMP violations. Source: Drug GMP Report

In a case that centered on labeling, an appeals court overturned a federal court ruling that GlaxoSmithKline was liable for the suicide of an attorney who took a generic of…

In another twist in the worldwide recall of the contaminated blood pressure medication, valsartan, the FDA released two Form 483 reports issued to the API’s manufacturer in China after inspections…

The FDA issued Form 483s to three companies for an array of issues, such as poor recordkeeping and inadequate employee training. Source: Drug GMP Report

The FDA hit five facilities with warning letters, citing them for multiple violations, including a failure to test for conformity. Source: Drug GMP Report

Australia’s Therapeutic Goods Administration issued draft guidance for sponsors on prescription drug boxed warnings recommending the use of formats designed to instantly grab readers’ attention. Source: Drug GMP Report

The FDA issued Form 483s to U.S. and foreign drugmakers, citing violations for sanitation issues, unreliable data and nonconformances, among other observations. Source: Drug GMP Report

Drug sponsors and investigators should work with organizations that offer either interoperable or integrated electronic health records or electronic data capture systems, the FDA said in a final guidance. Source:…